Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

Exclusion Criteria

• •1. Patients with hemophagocytic lymphohistiocytosis;
• •2. Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;
• •3. The subject's previous history of antineoplastic therapy meets one of the following conditions:
• •1. Failure to achieve CR or PR after previous treatment with mitoxantrone or mitoxantrone liposome, or relapse within 6 months after treatment;
• •2. Prior treatment with anthracyclines or anthraquinones and cumulative dose of doxorubicin \> 550 mg/m2 (liposomal doxorubicin \> 2000 mg/m2, epirubicin \> 1000 mg/m2, pirarubicin \> 1000 mg/m2, mitoxantrone \> 160 mg/m2);
• •3. Received anti-tumor treatment (including chemotherapy, targeted therapy, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives (whichever came first) before the first use of the study drug;
• •4. patients who received autologous hematopoietic stem-cell transplantation or allogeneic hematopoietic stem-cell transplantation within 100 days of the first dose of treatment;
• •4. Hypersensitivity reaction to any study drug or its components;
• •5. Patients with known allergy to any component of the monoclonal antibody;
• •6. Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome;
• •7. Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B SurfaceAntigen (HBsAg) or hepatitis B core Antibody (HBcAb) or Hepatitis C Virus (HCV) during the screening period HCV) antibody positive patients must be further tested for Hepatitis B Virus (HBV) DNA (no more than 1000 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of detection of the assay), Enrollment in the trial occurred after the exclusion of patients with active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus (HBV) carriers, medically stable hepatitis B (DNA \> 1000 copies /mL or 500IU/mL) and cured hepatitis C patients are eligible for enrollment.
• •8. Cardiac function and disease is one of the following:
• •1. long QTc syndrome or QTc interval \>480 ms;
• •2. complete left bundle branch block, degree II or III atrioventricular block;
• •3. severe, uncontrolled arrhythmia requiring medical treatment;
• •4. New York College of Cardiology grade ≥ III;
• •5. cardiac ejection fraction (LVEF) less than 50%;
• •6. a history of myocardial infarction, unstable angina, major unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months before recruitment;
• •9. Receive live attenuated vaccine (except influenza vaccine) within 4 weeks before enrollment or during the study period;
• •10. Previous or current concurrent cancer (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the previous five years);
• •11. Those with central nervous system involvement;
• •12. Lactating women;
• •13. Subjects receiving systemic glucocorticoid therapy or other immunosuppressive therapy for a condition within 14 days before starting study treatment (topical, ocular, intra-articular, nasal, and inhaled glucocorticoids were allowed (minimal systemic absorption); Short-term (≤ 7 days) use of glucocorticoids was permitted for preventive treatment (e.g., contrast allergy) or for the treatment of nonautoimmune conditions (e.g., delayed hypersensitivity from contact allergens).
• •14. Had undergone major surgery within 28 days before starting study treatment, or had undergone radiation therapy within the previous 90 days.